Declaration for Medical Devices

Declaration of Conformity for Medical Devices is a formally documented statement by the manufacturer regarding the conformity of medical devices to established requirements (Technical Regulations Nos. 753, 754, 755, EU Directives 93/42/EEC, 98/79/EC, and 90/385/EEC or Regulations 2017/745 and 2017/746).

What information should be included in the Declaration of Conformity?

The declaration includes information about one or several medical devices manufactured by the producer, including the name, code, or other unique identifiers of such devices, as well as information about the authorized representative in Ukraine.

The Declaration of Conformity for a medical device is a separate document issued by the manufacturer, in which they confirm that their product meets the requirements and safety standards established for medical devices.

What requirements for the declaration are established by Technical Regulation No. 753 regarding medical devices?

The Technical Regulation does not specify detailed requirements for the format of the Declaration of Conformity, only the necessity of its preparation with information about the products manufactured by the producer, the producer’s location, and the location of the authorized representative (for foreign manufacturers).

Despite the general requirements in the Technical Regulation, during customs control or market surveillance checks, attention is also paid to the presence of additional information in the declaration, namely:

• the presence of a statement on the conformity of medical devices to the Technical Regulation
• The number and date of issuance of the conformity certificate (for medical devices of classes Is, Im, IIa, IIb, and III)
• The class of the medical device and the rule of the Technical Regulation under which the device was classified
• The conformity assessment procedure applicable to the specified devices

The declaration is an important document that confirms that the medical device is safe to use, helps avoid negative consequences from improper use, and ensures product quality. Therefore, the manufacturer must issue this declaration before selling their medical device to demonstrate compliance with all safety requirements and standards.

You can obtain a free template of the declaration by leaving a request – and we will definitely send it to you.